Clinical trials: Safety Study
Influenza A Virus, H7N9 Subtype
Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9 Disease in Adults 50 to 70 Years Old
H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that affected many older adults. This study will evaluate the safety of and immune response to a live attenuated H7N9 vaccine in adults 50…
- Trial name
- NCT02274545
- Testing
- H7N9 Anhui 2013/AA ca, Inactivated subvirion H7N9 vaccine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obesity
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
- Trial name
- SLEEVE (NCT00722995)
- Testing
- Sleeve gastrectomy, Gastric Bypass
- Where
- France
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Gout; Hyperuricemia
Single Dose Study of SHR4640 in Healthy Subjects
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Trial name
- NCT02815839
- Testing
- SHR4640
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Health, Subjective
Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer
A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers
- Trial name
- NCT05232175
- Testing
- ALT-BB4, 0.9%NaCl
- Where
- South Korea
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Alteogen, Inc.
Infections, Papillomavirus
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or…
- Trial name
- NCT01462357
- Testing
- Cervarix, Gardasil
- Where
- 21 sites in France, Hong Kong and 2 more
- Volunteers
- 1,079 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infant Development, Safety Issues
Safety of Bifidobacterium Breve PS1 for Infants
The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk.
- Trial name
- NCT05973812
- Testing
- Infant formula supplemented with Bifidobacterium breve PS1, Infant formula NOT supplemented with Bifidobacterium breve PS1
- Where
- 3 sites in Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
Schizophrenia
First Time in Human Study (FTIH) With Positron Emission Tomography (PET)
This study described in the present protocol consists of two sections. Part A is the first administration into man to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK1144814.
- Trial name
- NCT01381419
- Testing
- GSK1144814
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Rabies
A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects
The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years…
- Trial name
- NCT02491541
- Testing
- Changchun Werersai, Jilin Maifeng
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Plasmodium Falciparum Infection
Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of Three or Five Administrations of GAP3KO Sporozoites
This Phase 1 trial will include 16 subjects who will receive the Genetically-attenuated p52-/p36-/sap1- Plasmodium falciparum Parasites (GAP3KO) vaccine administered by the bite of approximately 200 infected Anopheles stephensi…
- Trial name
- NCT03168854
- Testing
- Genetically-attenuated p52-/p36-/sap1- Plasmodium falciparum parasite (GAP3KO) strain, Malaria challenge
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Safety, Tolerability
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Cancer
- Trial name
- NCT02054754
- Testing
- Dexanabinol Dose Level 1, Dexanabinol Dose Level 2, Dexanabinol Dose Level 3
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- e-Therapeutics PLC
Influenza, Human
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine in Population Aged 3-8 Years
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
- Trial name
- NCT05138705
- Testing
- Quadrivalent Influenza Virus Split Vaccine
- Where
- China
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Healthy Subjects
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.
- Trial name
- NCT02873156
- Testing
- E2027
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
A Device Study in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given.
- Trial name
- NCT04848402
- Testing
- On-Body Delivery System (OBDS)/Multiple Bolus Injector, Single Auto Injector
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Vaccine Reaction
Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant
Streptococcus pneumoniae is a common bacteria and major cause of serious infections like bloodstream infections, pneumonia, and meningitis.
- Trial name
- PCV-LITE (NCT06986239)
- Testing
- PCV-LITE, PCV-LITE+LVA, PCV20
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- LiteVax BV
Chikungunya Virus
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
- Trial name
- NCT03325075
- Testing
- VAL-181388
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Healthy Participants
A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants
The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants.
- Trial name
- NCT06555601
- Testing
- UCB3101
- Where
- Belgium
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Tuberculosis
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infection
Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers
The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic.
- Trial name
- VRI01 (NCT02038842)
- Testing
- LIPO-5, MVA HIV-B (MVATG17401), GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
- Where
- France
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
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